Senior Design Quality Engineer

Hydrafacial LLC.; Long Beach (CA); On-site; USD 93,500 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

FSAs

HSAs

Life insurance

Disability insurance

401(k) with employer match

Paid time off

Paid holidays

Job summary

Hydrafacial LLC. is seeking a Senior Design Quality Engineer in Long Beach, CA. The role combines design quality leadership with R&D documentation, ensuring compliance with FDA 21 CFR 820.30 and ISO standards.

This hybrid position requires writing, reviewing, and organizing DHF and related records. The successful candidate will have a BS in engineering, 5+ years in regulated documentation, and SolidWorks experience to create 2D drawings.

Qualifications

• BS degree in Engineering or related technical field
• 5+ years of experience writing and leading documentation in a regulated environment
• Experience with SolidWorks in creating 2D drawings
• Knowledge of standards for Design Controls (FDA 21 CFR 820.30) and generating and maintaining Design History Files (DHF)
• Complete understanding of document control practices (ECR’s, ECO’s, Deviations, etc.)

Responsibilities

• Ensure R&D and other disciplines are following good documentation practices.
• Update existing R&D procedures and forms to align with the latest standard (FDA and ISO) and internal design practices.
• Ensure R&D and other disciplines are following through on design control and other key documentation.
• Manage the creation of overarching design control documentation.
• Assisting in writing requirements, protocols, reports, and other key documentation, as well as creating CAD drawings.
• Organize documentation captured during research and product development that will be shared with the legal team for patents.
• Other duties as assigned.

Skills

SolidWorks

Documentation

Design Controls (FDA 21 CFR 820.30)

DHF management

Document control

Technical writing

Communication skills

Education

Bachelor's degree in Engineering or related technical field

Master of Science in a related technical field

Tools

SolidWorks

Job description

## Senior Design Quality Engineer - Long Beach, CAPostulerlocations: USA, California - Long Beachtime type: Full timeposted on: Offre publiée il y a 6 joursjob requisition id: JR101482**A propos de nous**Hydrafacial is a global category-creating company focused on bringing innovative products to market and delivering beauty health experiences by reinventing our consumer’s relationship with their skin, their bodies and their self-confidence.Every person here is a key player in our success. We are firm believers in making the little things count each day so the big things will follow. If this sounds like you, come check us out! This is the perfect opportunity to work with some of the best leaders in the industry while you gain the global and strategic experience to add to your professional toolbox.**Job Description:**The Senior Design Quality Engineer is responsible for research, product development, and sustaining engineering documentation. This is a hybrid role based out of our Long Beach, CA headquarters, with designated in-office collaboration days each week.**What you’ll do:**Primary Responsibilities:* Ensure R&D and other disciplines are following good documentation practices.* Update existing R&D procedures and forms to align with the latest standard (FDA and ISO) and internal design practices.* Ensure R&D and other disciplines are following through on design control and other key documentation.* Manage the creation of overarching design control documentation.* Assisting in writing requirements, protocols, reports, and other key documentation, as well as creating CAD drawings.* Organize documentation captured during research and product development that will be shared with the legal team for patents.* Other duties as assigned.**What you need to know:**Experience/Skills/Education:Required:* BS degree in Engineering or related technical field* 5+ years of experience in writing and leading documentation in a regulated environment* Experience with SolidWorks in creating 2D drawings* Knowledge of standards for Design Controls (FDA 21 CFR 820.30) and generating and maintaining Design History Files (DHF)* Complete understanding of document control practices (ECR’s, ECO’s, Deviations, etc.)Desired:* MS in a related technical field.* Lean Six Sigma* Strong communication and presentation skills.**We mean it when we say you’ll LOVE this role.**Base Pay: $93,500 - $120,000 + bonusAn employee’s pay position within the salary range will be based on several factors, including but not limited to relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, travel requirements, revenue-based metrics, any contractual agreements, and business or organizational needs. The range listed is just one component of HydraFacial’s total rewards package for our employees. Other rewards may include annual bonuses, long-term incentives based on level, paid time off, and region-specific benefits. Come grow and GLOW with us!**What else can you expect with HydraFacial?** PERKS! Benefits include: Medical insurance, dental insurance, vision insurance, FSAs, HSAs, accident insurance, pet insurance, company-paid life and AD&D insurance, company-paid long-term and short-term disability insurance, 401(k) with employer match, paid time off (PTO), and paid holidays.#LI-OnsiteHydrafacial is proud to be an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, sex, religion, sexual orientation, national origin, gender identity, gender expression, age, disability, genetic information, pregnancy or any other protected characteristic as outlined by color, federal, state or local laws. We are committed to working with and providing accommodation to applicants with physical and mental disabilities. Hydrafacial does not accept unsolicited assistance or resumes/CVs from third party search firms. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral or CV/resume submitted by a search firm to any employee at our company without a valid written search agreement. If we need additional support, we will be sure to reach out directly to one of our preferred providers. Please no phone calls or emails.